K250983 is an FDA 510(k) clearance for the Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172). This device is classified as a Allergen And Vaccine Delivery Needles (Class II - Special Controls, product code SCL).
Submitted by Asistan Medikal (Oguzeli, Gaziantep, TR). The FDA issued a Cleared decision on January 30, 2026, 305 days after receiving the submission on March 31, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests..
| 510(k) Number | K250983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | January 30, 2026 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | SCL - Allergen And Vaccine Delivery Needles |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests. |